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Got Design Controls Down? Good, Now Start Working on Spin Control

Originally Published March 2000

EDITOR'S PAGE

Got Design Controls Down? Good, Now Start Working on Spin Control

We are all painfully aware of how media-driven our society has become. If you are not in the public eye, you run the risk of irrelevance for an overwhelming segment of the U.S. population. The medical device industry is not immune to this, and it needs to find more-effective ways of informing the public of its achievements. That was one of the overarching themes at the recent Global Medical Device Conference in Cancún, Mexico, where almost 200 regulatory and industry officials from around the world discussed the state of industry. Guidant CEO Ron Dollens set the tone when he introduced the first session of the two-day conference by urging industry leaders to become more media savvy.

"People don't know us," said Dollens. "They relate treatment to a procedure, a hospital, or a physician, not to a medical device. When it's made clear to the public what our contribution as an industry has been, they become incredibly supportive." That support can be leveraged to achieve goals that threaten to elude industry, Dollens stressed.

Gaining patient access to medical innovation should be the bedrock of industry. These efforts are stymied, however, by burdensome regulatory procedures and intensified government efforts to contain healthcare costs. Reimbursement was raised as a case in point.

European industry has been sounding the alarm for some time on the trend to reinstitute national regulatory schemes under the guise of reimbursement. Being able to put a device on the market doesn't count for much if there is no incentive for the consumer to buy it.

The vogue for healthcare technology assessments (HCTA) on both sides of the Atlantic was also hotly debated at the conference. While these studies have the potential, in theory, to benefit innovative products, reality suggests otherwise. As Alan Kent, head of the UK regulatory authority for medical devices, noted: HCTA agencies never seem to look at products where the outcome might be that society would benefit from more products of this type or from accelerated approval times.

Clearly, industry must be more persuasive in presenting its views, stressed Dollens. "Policymakers must understand that in those cases where technology results in increased costs, those costs may well be a result of patients living longer, more productive lives. Death is often the least expensive outcome," he pointed out.

"This industry makes a difference in patients' lives," Dollens continued. "We need to engage in strong collaborative efforts. . . customers can be our strongest advocates for innovation."

And it doesn't hurt that they happen to be voters.


By way of introduction

You may have noticed that a new mug shot and signature have appeared on this page. Some of you already know me—I have been editor of MPMN's sister publication European Medical Device Manufacturer for the past three years, a position I will continue to hold.

I intend to maintain and indeed strengthen MPMN's mission of providing industry professionals with the most comprehensive sourcebook of products and services for the device industry. I also plan to expand coverage of core issues and to introduce some new features; continuing the redesign of the magazine that has met with such approval among readers is also at the top of my to-do list.

I am very excited at having been named editor of MPMN. I hope that the magazine's continued development in the months ahead will give you cause for excitement, as well.

Norbert Sparrow
[email protected]



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